Brain HealthPhase 2/3NCT02541929
Fish Oil Brain Delivery Study
A Phase 2/3 study testing Docosahexaenoic acid in people with Brain Health, run by University of Southern California at 1 site in United States.
Trial summary
Docosahexaenoic acid (DHA) is an essential omega-3 fish oil. DHA is critical to the structure and function of brain cells. DHA fish oil has been shown to be beneficial in cognition in several animal studies; however, this effect in human studies is not clear. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Health
- What is being tested?
- Docosahexaenoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 30 Sep 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages 55 and above
- at risk of Alzheimer's disease such as family history of dementia
- women have to be postmenopausal
Who cannot join
- Current smokers (or a recent history of smoking within less than 5 years),
- Having a history of cardiovascular disease defined by a prior heart attack, coronary bypass or percutaneous luminal angioplasty, kidney failure or blindness.
- a diagnosis of cancer in the past 6 months, uncontrolled hyper- or hypothyroidism
- Taking anti-coagulants such as warfarin
- Anyone consuming n-3 PUFA capsules for the last 3 months.
- regular exercisers (>5 X30min of aerobic exercise per week),
- heavy drinkers (>30 units of alcohol per week). One unit of alcohol is about equal to: half a pint of ordinary strength beer, lager or cider (3-4% alcohol by volume); or. a small pub measure (25 ml) of spirits (40% alcohol by volume); or. a standard pub measure (50 ml) of fortified wine such as sherry or port (20% alcohol by volume)
- If participants have scores that lie 2 SD outside the means of the neuropsychiatry tests administered, they will have mild cognitive impairment. Participant's with mild cognitive impairment are excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Keck School of Medicine
Los Angeles, California, 90033
About this study
Docosahexaenoic acid (DHA) is an essential omega-3 fish oil. DHA is critical to the structure and function of brain cells.
DHA fish oil has been shown to be beneficial in cognition in several animal studies; however, this effect in human studies is not clear. It is not known how much dietary fish oil can get into the human brain. Thus, exploring fish oil delivery in human brains is critical for designing appropriate interventions.
Read the detailed description
- The investigators goal is to study how different people deliver DHA to the brain.
- The study will only require two visits six months apart and involve taking DHA during these 6 months.
- Participants will receive DHA supplements for the study duration and a compensation for each study visit.
- Blood and cerebrospinal fluid levels of DHA will be measured before and after taking DHA.
- Brain imaging by MRI will be obtained at baseline and at conclusion of study
- This study will help us learn how much of the ingested DHA goes to the brain.
- Conditions
- Brain Health
- Being tested
- Docosahexaenoic acid
- Keywords
- Alzheimer's disease, Docosahexaenoic acid, brain health, memory, fish oil, cognition, DHA, omega 3 fatty acid, brain
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acidDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| DHA | Experimental | DHA (2grams/day) for 26 weeks Receives: Dietary Supplement: Docosahexaenoic acid |
| placebo | Placebo comparator | placebo (4 capsules per day) for 26 weeks Receives: Dietary Supplement: Docosahexaenoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in DHA levels in the CSF following dietary DHA supplementation
Measured: 6 months
Secondary outcomes (1)
Brain MRI
Structural and functional connectivity
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start30 Jun 2016
- Primary completion30 Nov 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Hussein Yassine, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541929
- Sponsor's protocol ID
- HS-14-00864
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2015
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bantugan MA, Xian H, Solomon V, Lee M, Cai Z, Wang S, Duro MV, Kerman BE, Fonteh A, Meuret C, Li M, Braskie MN, McIntire LBJ, Jurin L, Oberlin S, Evans J, Davis R, Mack WJ, Abdullah L, Yassine HN. Associations of ApoE4 status and DHA supplementation on plasma and CSF lipid profiles and entorhinal cortex thickness. J Lipid Res. 2023 Jun;64(6):100354. doi: 10.1016/j.jlr.2023.100354. Epub 2023 Mar 22.
PubMed 36958720Arellanes IC, Choe N, Solomon V, He X, Kavin B, Martinez AE, Kono N, Buennagel DP, Hazra N, Kim G, D'Orazio LM, McCleary C, Sagare A, Zlokovic BV, Hodis HN, Mack WJ, Chui HC, Harrington MG, Braskie MN, Schneider LS, Yassine HN. Brain delivery of supplemental docosahexaenoic acid (DHA): A randomized placebo-controlled clinical trial. EBioMedicine. 2020 Sep;59:102883. doi: 10.1016/j.ebiom.2020.102883. Epub 2020 Jul 17.
PubMed 32690472
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Brain Delivery Study
- ClinicalTrials.gov ID
- NCT02541929
- Acronym / sponsor ID
- HS-14-00864
- Conditions
- Brain Health
- Keywords
- Alzheimer's disease, Docosahexaenoic acid, brain health, memory, fish oil, cognition, DHA, omega 3 fatty acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Docosahexaenoic acid (DHA) is an essential omega-3 fish oil. DHA is critical to the structure and function of brain cells.
DHA fish oil has been shown to be beneficial in cognition in several animal studies; however, this effect in human studies is not clear. It is not known how much dietary fish oil can get into the human brain. Thus, exploring fish oil delivery in human brains is critical for designing appropriate interventions.
Detailed description
- The investigators goal is to study how different people deliver DHA to the brain.
- The study will only require two visits six months apart and involve taking DHA during these 6 months.
- Participants will receive DHA supplements for the study duration and a compensation for each study visit.
- Blood and cerebrospinal fluid levels of DHA will be measured before and after taking DHA.
- Brain imaging by MRI will be obtained at baseline and at conclusion of study
- This study will help us learn how much of the ingested DHA goes to the brain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA | Experimental | Dietary Supplement: Docosahexaenoic acidDHA (2grams/day) for 26 weeks |
| placebo | Placebo comparator | Dietary Supplement: Docosahexaenoic acidplacebo (4 capsules per day) for 26 weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages 55 and above
- at risk of Alzheimer's disease such as family history of dementia
- women have to be postmenopausal
Key exclusion criteria (8 listed)
- Current smokers (or a recent history of smoking within less than 5 years),
- Having a history of cardiovascular disease defined by a prior heart attack, coronary bypass or percutaneous luminal angioplasty, kidney failure or blindness.
- a diagnosis of cancer in the past 6 months, uncontrolled hyper- or hypothyroidism
- Taking anti-coagulants such as warfarin
- Anyone consuming n-3 PUFA capsules for the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexaenoic acid | Dietary supplement | DHA, placebo |
Primary outcome
changes in DHA levels in the CSF following dietary DHA supplementation
Time frame: 6 months
1 secondary outcome
Brain MRI
Time frame: 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 36958720Bantugan MA, Xian H, Solomon V, Lee M, Cai Z, Wang S, Duro MV, Kerman BE, Fonteh A, Meuret C, Li M, Braskie MN, McIntire LBJ, Jurin L, Oberlin S, Evans J, Davis R, Mack WJ, Abdullah L, Yassine HN. Associations of ApoE4 status and DHA supplementation on plasma and CSF lipid profiles and entorhinal cortex thickness. J Lipid Res. 2023 Jun;64(6):100354. doi: 10.1016/j.jlr.2023.100354. Epub 2023 Mar 22.
- Derived from this study: PubMed 32690472Arellanes IC, Choe N, Solomon V, He X, Kavin B, Martinez AE, Kono N, Buennagel DP, Hazra N, Kim G, D'Orazio LM, McCleary C, Sagare A, Zlokovic BV, Hodis HN, Mack WJ, Chui HC, Harrington MG, Braskie MN, Schneider LS, Yassine HN. Brain delivery of supplemental docosahexaenoic acid (DHA): A randomized placebo-controlled clinical trial. EBioMedicine. 2020 Sep;59:102883. doi: 10.1016/j.ebiom.2020.102883. Epub 2020 Jul 17.
- Yassine Lab WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Docosahexaenoic acid in people with Brain Health, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in DHA levels in the CSF following dietary DHA supplementation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02541929, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.